How PLM can help to fulfil the MDR requirements

Teamcenter is one of the most widely used technologies for Digital Product Lifecycle Management. The specialized "Medical Device Solution" module for Teamcenter simplifies collaboration and digital communication between technical, commercial and creative departments.

The design control processes in the medical device industry differ from the processes of other industries. The following requirements are taken into account by the "Medical Device Solution"  based on Teamcenter:

  • Traceability from requirements to product structure and utilization in the field
  • Management of requirements
  • Design History File (DHF) based on templates
  • Risk Analysis: Failure Mode and Effects Analysis (FMEA)
  • Device Master Record (DMR) / Technical File (TF) / Design Transfer
  • Quality (Issue / CAPA)
  • ISO 13485 / FDA / GxP

 

Your benefits with the Medical Device Solution

 

Specials:

  • Checklist wizard to ensure all quality-relevant documents for Design Control
  • Just a click to the Technical File (TF) and / or country-specific documentation
  • Always verifiable status of the product development
  • cross-team and consistent view of product development progress
  • Intelligent Design Control

 

Reduce Time-To-Market

  • Quick search and accessibility of relevant information
  • Faster response to market demands, feedbacks and events

 

Reduce Interal Costs

  • Rapid assessment of the impact of changes in development and production, including changes in legislation and standards
  • No duplicate information in authorized revisions
  • No redundant data
  • Current revision available for everyone

 

Improve Quality

  • Simple reporting, clear view of complex data and process monitoring
  • Optimized teamwork in processes of development and technical engineering
  • Clear communication between technicians and commercial people

 

Reduce Risks

  • Reduced non-compliance risk of quality regulations
  • Reduced risk of penalties for insufficient documentation of the products
Further info
Product groups:
Software
    PLM software


Your contact person for this product highlight
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Markus Frei

Siemens Industry Software GmbH

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